BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED S8 FLOW GENERATOR

    MDR report key: 852224 · Received May 11, 2007

    Report

    Report Number
    MW1042882
    Event Type
    Injury
    Date Received
    May 11, 2007
    Date of Event
    April 1, 2007
    Report Date
    May 11, 2007
    Manufacturer
    RESMED LTD.
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POWER SUPPLY TO RESMED S8 FLOW GENERATOR IS INTERRUPTED DURING USE DUE TO PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED S8 FLOW GENERATOR CPAP NHJ RESMED LTD. HUMIDAIRE S8 ESCAPE *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening